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| ID | Type | Description | Link |
|---|---|---|---|
| H-56001 | Other Identifier | Baylor College of Medicine | |
| R41AA032157 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| The Menninger Clinic | UNKNOWN |
| Baylor College of Medicine | OTHER |
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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The study will involve a 5-day tAN treatment to attenuate alcohol withdrawal syndrome (AWS) and alter resting state functional connectivity (RSFC) between OFC and striatum in patients with alcohol use disorder (AUD). Enrolled participants will wear the tAN device on-site (at The Menninger Clinic) for the 5-day detox treatment period. Participants with AUD will be single-blinded randomized into 2 groups - a treatment group (active tAN) and a placebo group (sham tAN). Each group will consist of five separate time points - admission, screening, baseline, tAN treatment, and post tAN treatment. Clinical measures collected before, during, and after treatment will include alcohol withdrawal severity, craving, benzodiazepine usage, and assessments of depression and suicidal behaviors. Participants will undergo MRI scans before and after the treatment period to assess changes in brain connectivity and their relationship to clinical outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tAN | Experimental | Participants will have the device applied on-site (at the Menninger Clinic) and will be required to wear the device for a minimum of 4 hours of stimulation per day. Study assessments will be collected at the time of, prior to, and at the conclusion of each tAN treatment session. Active tAN stimulation will be administered in addition to the participant's standard of care treatment. |
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| Sham tAN | Sham Comparator | Participants will have the device applied on-site (at the Menninger Clinic) and will be required to wear the device for a minimum of 4 hours of stimulation per day. Study assessments will be collected at the time of, prior to, and at the conclusion of each sham tAN treatment session. Sham tAN stimulation will be administered in addition to the participant's standard of care treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sparrow Ascent | Device | The Sparrow Ascent is an FDA-cleared (K230796) wearable, battery-operated, neurostimulation system designed to transcutaneously stimulate nerves on and around the auricle. The system is comprised of a Patient Controller, cable, and 24-hour disposable earpiece. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar) | The CIWA-Ar is a validated, clinician-administered scale used to assess the severity of alcohol withdrawal symptoms. The tool rates ten symptom domains-including nausea, tremor, anxiety, agitation, sweating, sensory disturbances, and orientation-to generate a total score that reflects withdrawal severity and guides clinical management. Higher scores indicate more severe withdrawal. | Every 4 hours during the tAN treatment (Days 2-6) |
| Average benzodiazepine use | Benzodiazepines are commonly used to manage symptoms of alcohol withdrawal and are administered as needed based on clinical severity. Tracking benzodiazepine usage provides an indirect measure of withdrawal intensity, as higher medication requirements typically reflect more severe withdrawal symptoms, while lower usage indicates milder withdrawal. | Every 4 hours during the tAN treatment (Days 2-6) |
| Measure | Description | Time Frame |
|---|---|---|
| Penn Alcohol Craving Scale (PACS) | PACS is a validated self-report questionnaire that measures the intensity, frequency, and duration of alcohol craving over the past week. It consists of five items assessing desire to drink, anticipated likelihood of drinking, and perceived control over drinking-related thoughts. Each item is rated on a 0-6 scale, with higher total scores indicating greater craving severity. |
| Measure | Description | Time Frame |
|---|---|---|
| Prediction of Alcohol Withdrawal Severity Scale (PAWSS) | PAWSS is a validated clinician-administered screening tool used to identify individuals at risk for developing moderate to severe alcohol withdrawal. The scale includes 10 items assessing historical, clinical, and laboratory factors associated with withdrawal risk. A total score of 4 or higher indicates high risk for complicated withdrawal. | Screening |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hyuntaek Oh, PhD | Contact | (713) 275-5019 | hyuntaek.oh@bcm.edu | |
| Caroline Benner | Contact | (210) 624-8046 | clinicaltrials@sparkbiomedical.com |
| Name | Affiliation | Role |
|---|---|---|
| Navid Khodaparast, PhD | Spark Biomedical, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Menninger Clinic | Recruiting | Houston | Texas | 77035 | United States |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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This study is designed as a randomized, single-blind, sham-controlled trial. Participants will be randomized in a 1:1 ratio to one of two treatment groups: (1) Active tAN and (2) Sham tAN
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| Sparrow Ascent (Sham) | Device | Participants will have the earpiece applied and the cable connected to the Patient Controller, but tAN stimulation will not be turned on. The sham device has an identical appearance to the active device. |
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| Before Day 2 and after tAN treatment on Day 6 |
| Montgomery-Asberg Depression Scale (MADRS) | MADRS is a clinician-administered measure designed to assess the severity of depressive symptoms. The scale includes 10 items that evaluate core features of depression such as mood, anxiety, sleep disturbance, concentration, and suicidal ideation. Each item is scored from 0 to 6, with higher total scores indicating more severe depression. | Before Day 2 and after tAN treatment on Day 6 |
| Suicidal Behaviors Questionnaire-Revised (SBQ-R) | SBQ-R is a validated, self-report measure used to assess past suicidal thoughts and behaviors, as well as current risk. The questionnaire includes four items that evaluate lifetime suicidal ideation and attempts, recent ideation, threat of future suicidal behavior, and self-reported likelihood of acting on suicidal thoughts. Scores range from low to high risk, with higher scores indicating greater concern for suicidal behavior. | Before Day 2 and after tAN treatment on Day 6 |